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Visual acuity is the relative ability of the eye to resolve detail that is usually expressed as the reciprocal of the minimum angular separation in minutes of two lines just resolvable as separate and that forms in the average human eye an angle of one minute.
Visibly Inc. has developed a method for determining a patient's visual acuity electronically via a web-based software system that can be self-administered wherever convenient. This method provides an efficient alternative for people to have immediate access to visual acuity measurements.
The Visibly Digital Acuity Product (VDAP) is a web-based, self-guided software application intended for use by adults, ages 22 to 40, at home, to evaluate visual acuity with or without correction. The standalone software application allows the user to interface with the software via a web browser on two internet-enabled devices:
The software allows users to view and respond to displayed optotypes and uses the responses to categorize a user's visual acuity into one of two buckets:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visibly Digital Acuity Product | Experimental |
| |
| ETDRS Visual Acuity Lane Test | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visibly Digital Acuity Product | Device | The order of testing (two VDAP home environments and ETDRS) will be randomly assigned for each subject as one of four sequences:
Where E denotes the ETDRS assessment, V1 denotes the VDAP assessment in home environment 1, and V2 denotes the VDAP assessment in home environment 2. The randomization will be blocked in groups of 4 subjects to ensure balance for the VA testing sequences. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness | The proportion of study eyes with VDAP VA of 20/25 or better 20/25 or better [Positive Predictive Value (PPV)] | Up to 3 hours |
| Reproducibility | The proportion of study eyes which receive the same VA classification (20/25 or Better vs. Worse than 20/25) for the two VDAP tests | Up to 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness | The proportion of subjects with matching VDAP and ETDRS VA classifications (20/25 or Better vs. Worse than 20/25) for both eyes (study eye and non-study eye) | Up to 3 hours |
| Reproducibility |
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Inclusion Criteria:
Exclusion Criteria:
1. Have any of the following conditions (based on subject report):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States | ||
| Core, Inc |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 31, 2025 | Apr 17, 2025 | 3 |
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The proportion of subjects with matching VDAP VA classifications (20/25 or Better vs. Worse than 20/25) for the two VDAP tests for both eyes (study eye and non-study eye)
| Up to 3 hours |
| Shelby |
| North Carolina |
| 28150 |
| United States |
| Total Eye Care | Memphis | Tennessee | 38119 | United States |